Sr. Engineer/Principal Engineer - MSAT - Upstream
Boehringer Ingelheim Fremont Inc. - Boehringer Ingelheim is one of the world's leading biopharmaceutical contract development and manufacturing organizations. Boehringer Ingelheim Fremont Inc. is currently searching for a talented and innovative Senior Engineer to join the MSAT (Manufacturing Science & Technology) group in the Process Science department at Boehringer Ingelheim’s Fremont, CA location.
The primary purpose of the Senior Engineer position is to provide process development support for commercial scale manufacturing through development and execution of projects, performance of experiments and analysis of complex data in the Upstream Manufacturing Science and Technology (MSAT) group. The person should have technical and scientific expertise of upstream cell culture and harvest unit operations, and should be able to execute against specific deliverables developed by department leadership. The Senior Engineer must live the BI values and promote a positive work environment for others. This position may also support New Product Introduction and GMP operations in the Disposables Clinical Manufacturing Facility to produce drug substance under GMP/GLP conditions for toxicology and clinical studies.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities:
- Use scale-up experience, facility specific knowledge and engineering principles to troubleshoot equipment and
processes; anticipate potential problems and propose risk mitigations and proactive solutions
- Support large-scale manufacturing operations through robust scale-up and implementation of new Upstream processes and equipment
- Perform process design and facility fit activities, and design and execution of bench scale experiments as required to support large-scale GMP manufacturing processes
- Develop / execute plans and /or experiments to investigate process related deviations in Upstream areas in a timely and conclusive manner and propose comprehensive process solutions and improvements
- Author technical documentation to support deviations, experiments and other activities
- Support process related raw material qualification activities
- Effectively communicate investigational designs, results and recommendations to internal teams and customers, with potential interaction with external clients and customers
- Use knowledge of statistical data mining and techniques to perform data analysis and mining of complex data sets to support continued process verification (CPV) and ongoing GMP production
- Support implementation of continuous process improvements in innovation and technology through identification, development and execution of process and procedural changes
- May support New Product Introduction and GMP operations in the Disposables Clinical Manufacturing Facility to produce drug substance under GMP/GLP conditions for toxicology and clinical studies Senior Engineer Requirements & Desired Skills,
Experience and Abilities:
- At least Bachelor’s degree from an accredited institution with five plus (5+) OR Master’s from an accredited institution with three plus (3+) OR PhD from an accredited institution with zero plus (0+) years of industry experience, statistical analysis skills.
- Technical knowledge of Upstream manufacturing principles, techniques and equipment
- Technical knowledge in process science area, preferably late-stage and commercial products
- Knowledge of statistical data analysis techniques
- Understanding of validation of biopharmaceutical facilities, equipment and processes
- Drives continuous process improvements
- Ability to lead effectively in a matrixed organization
- Proven skills building and maintaining productive relationships with organizational partners such as manufacturing and quality
- Strong communication skills
- Project management experience
- Six Sigma experience will be a plus
- This position may be accountable to answer process related questions of regulators. The position must have expert knowledge of upstream processes and related manufacturing equipment and facility attributes for the BIFI site.
- Experience/Expertise in a scientific discipline (chemical/biochemical engineering, biopharmaceuticals, biotechnology, molecular biology, biochemistry, cell biology)
- Must be legally authorized to work in the United States without restriction
- Must be willing to take a drug test and post-offer physical (if required)
- Must be 18 years of age or older
Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies and operates globally with approximately 50,000 employees. Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Since we are privately held, we have the ability to take an innovative, longterm view. Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighbourhood’s where we live and work. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a
culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment verifications and drug screenings